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#EAPM heads for grand depart with newsletter and imminent ESMO round table

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Welcome, one and all, to the final European Alliance for Personalised Medicine (EAPM) update before le grand depart– before you go, do be sure to check out the EAPM newsletter, which is available here. And be sure to register in good time for the ESMO Virtual Congress 2020, at which EAPM will be organizing a round table on 18 September, bringing its stellar cast of specialists from the patients network, as well as experts from the oncology community and the European Medicine Agency (EMA) and European Parliament, writes EAPM Executive Director Denis Horgan. 

The agenda is available here, and you can register already here.

Bringing innovation to patients – choosing the right time to investigate transparency

A major pillar in bringing new, targeted medicines to patients is, of course, innovation. This, in the realm of health, means the translation of knowledge and insight into what we can call ‘value’. And that value covers the value to patients but also has to take into account value to healthcare systems, society and, of course, the manufacturers.  

Transparency and good governance is of course essential, but it must be asked whether, with all resources stretched to near breaking point, now is a good time for European Ombudsman Emily O’ Reilly to be requesting the European Centre for Disease Prevention and Control (ECDC) to provide a number of documents to evaluate its performance during the coronavirus pandemic. 

A request was made during the summer of 2017 when, again, in a similarly unpopular move, the European Ombudsman asked the European Medicines Agency to provide more information about its early dialogue procedures. O’Reilly’s  raises the issue of what the EU is trying to do with its own health regulation in bringing innovation to the patient, but is now really the right time? On verras… O’Reilly suggested a meeting between her inquiry team and the ECDC staff to further clarify and discuss any outstanding issues.

Surviving the pandemic – how different countries have fared

The latest statistics now available have provided one of the clearest pictures yet of how different countries have fared during the pandemic. It demonstrates that while the most devastating short-term and localized spikes in COVID-19 and other deaths were seen in Spain and Italy, England and the rest of the UK endured a longer period of convalescence, with significantly increased excess mortality – England had the highest levels of excess deaths of any country in Europe from January to June, according to a new analysis by the European Office for National Statistics (ONS). 

While Spain saw the worst weekly spike in deaths from all causes during the coronavirus pandemic, England had the “longest continuous period of excess mortality,” the ONS said. By the end of May, England had the highest cumulative mortality rate of any of the 23 countries for which data was available, followed by Spain, Scotland and Belgium. The worst local spike in Europe was in Bergamo, Italy in the week ending 20 March, where an excess mortality rate of 847% — or more than nine times the 2015 to 2019 average — was seen. The major city with the worst spike was Madrid, with excess mortality of 432% in the week ending 27 March.

Dancing, with tears in their eyes

Initially, sad news for everyone planning to put their cares aside with a good boogie – the Romanian government was supposedly planning to ban dancing on public terraces. But, according to Digi24, the powers that be pulled back from this potentially unpopular decision, choosing instead to announce new measures this past week to make wearing a mask mandatory in certain outdoor spaces, such as markets and boardwalks. Local authorities were mandated to decide the spaces and the time slots when people will be required to wear a mask.

France sets out COVID-19 vaccination planning

As the coronavirus pandemic continues, there is hope that one or more of the vaccines in development will be successful. France has revealed its early planning for implementation of a vaccine.  The Haute Autorité de Santé (HAS – High Authority for Health) said: “At the request of the Ministry of Solidarity and Health, the High Authority for Health is making preliminary recommendations to anticipate the development of the vaccine strategy against COVID-19 with a view to the future arrival of one or more vaccines.

Who to vaccinate? According to what scheme? By which professionals? To inform the public decision, the HAS draws the different possible vaccination strategies through four scenarios based on the level of circulation of the virus in the territory.”  

The strategy will be updated as the pandemic continues, ensuring the latest information is incorporated into the plan. In particular, the status and spread of the virus will be monitored.  What is clear now, however, is the need to prioritise medical and health professionals so that the risk of catching and passing on COVID-19 is reduced while essential work continues.

Dutch government not advising public to wear masks

On Wednesday (29 July) this week, the Dutch government said it will not advise the public to wear masks to slow the spread of coronavirus, asserting that their effectiveness has not been proven.The decision was announced by Medical Care Minister Tamara van Ark after a review by the country’s National Institute for Health (RIVM). The government will instead seek better adherence to social distancing rules after a surge in coronavirus cases in the country this week, Van Ark said at a press conference in The Hague. The decision bucks the current trend as many European countries have made masks mandatory in stores or crowded outdoor areas. Masks are currently required only on public transportation in the Netherlands and in airports.

WHO blames youth ‘letting their guard down’ 

Young people are relaxing on social distancing and other ant-coronavirus measures, and are part of the reason for the summer spikes in coronavirus, according to World Health Organization Director General Tedros Adhanom Ghebreyesus: “We have said it before and we’ll say it again: Young people are not invincible,” said Tedros. Countries across Europe are seeing increases in case numbers, with many fearing it’s the start of a second wave.

Coronavirus vaccine ‘not available this year’, WHO warns 

Hopes of a coronavirus vaccine before Christmas have been dashed by a World Health Organization (WHO) expert.   Mike Ryan, head of WHO's emergencies programme, said the first use of a COVID-19 vaccine cannot be expected until early 2021. He noted that several vaccines are now in phase three trials and none have failed so far in terms of safety or ability to generate an immune response. His comments come after Oxford University — one of the frontrunners in a race for a vaccine —  claimed there was still a chance it could deliver its experimental jab by Christmas if tests keep going according to plan.     One of the researchers working on the project had said that people in the most at-risk groups could get the first jabs in the winter. 

A vaccine is considered crucial for getting out of the coronavirus pandemic because it would be the only way to secure protection against catching it. It would work by injecting either a tiny piece of the virus into the body –  which would not make someone sick – or a clone of its DNA. This triggers an immune response which has long-term memory, so if a person is exposed to the coronavirus in real life, their body knows how to fight it quickly.  

Here is the link the newsletter again for the ESMO Agenda and to register

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Coronavirus disinformation: Online platforms took more actions fighting vaccine disinformation

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The Commission has published the new reports by Facebook, Google, Microsoft, Twitter, TikTok and Mozilla, signatories of the Code of Practice on Disinformation. They provide an overview of the evolution of the measures taken in January 2021. Google expanded its search feature providing information and a list of authorised vaccines in user's location in response to related searches in 23 EU countries, and TikTok applied the COVID-19 vaccine tag to over five thousand videos in the European Union. Microsoft co-sponsored the #VaxFacts campaign launched by NewsGuard providing a free browser extension protecting from coronavirus vaccines misinformation. Additionally, Mozilla reported that curated authoritative content from its Pocket (read-it-later) application gathered more than 5.8 billion impressions across the EU.

Values and Transparency Vice President Věra Jourová said: “Online platforms need to take responsibility to prevent harmful and dangerous disinformation, both domestic and foreign, from undermining our common fight against the virus and the efforts towards vaccination. But platforms' efforts alone will not suffice. It is also crucial to strengthen co-operation with public authorities, media and civil society to provide reliable information.”

Internal Market Commissioner Thierry Breton added: “Disinformation poses a threat that needs to be taken seriously, and platforms' response must be diligent, robust and efficient. This is particularly crucial now, when we are acting to win the industrial battle for all Europeans to have a fast access to safe vaccines.”

The monthly reporting programme has been recently extended and will continue until June as the crisis still unfolds. It is a deliverable under the 10 June 2020 Joint Communication to ensure accountability towards the public and discussions are ongoing on how to further improve the process. You will find more information and the reports here.

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Merkel says COVID variants risk third virus wave, must proceed carefully

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New variants of COVID-19 risk a third wave of infections in Germany and the country must proceed with great care so that a new nationwide shutdown does not become necessary, Chancellor Angela Merkel (pictured) told the Frankfurter Allgemeine Zeitung, writes Paul Carrel.

The number of new daily infections has stagnated over the past week with the seven-day incidence rate hovering at around 60 cases per 100,000. On Wednesday (24 February), Germany reported 8,007 new infections and 422 further deaths.

“Because of (variants), we are entering a new phase of the pandemic, from which a third wave may emerge,” Merkel said. “So we must proceed wisely and carefully so that a third wave does not necessitate a new complete shutdown throughout Germany.”

Merkel and state premiers in Germany, Europe’s most populous country and largest economy, have agreed to extend restrictions to curb the spread of the coronavirus until 7 March.

Hair salons will be allowed to reopen from 1 March, but the threshold for a gradual reopening of the rest of the economy targets an infection rate of no more than 35 new cases per 100,000 people over seven days.

Vaccines and comprehensive testing could allow for “a more regionally differentiated approach”, Merkel said in the newspaper interview, published online on Wednesday.

“In a district with a stable incidence of 35, for example, it may be possible to open all schools without causing distortions in relation to other districts with a higher incidence and schools that are not yet open,” she added.

“An intelligent opening strategy is inextricably linked with comprehensive quick tests, as it were as free tests,” she said. “I cannot say exactly how long it will take to install such a system. But it will be in March.”

Merkel described Anglo-Swedish firm AstraZeneca’s COVID-19 vaccine, which some essential workers have refused, as “a reliable vaccine, effective and safe.”

“As long as vaccines are as scarce as they are at the moment, you can’t choose what you want to be vaccinated with.”

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India warns of worsening COVID-19 situation, vaccinations to expand

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India announced an expansion of its vaccination programme on Wednesday (24 February) but warned that breaches of coronavirus protocols could worsen an infection surge in many states, write Krishna N. Das and Neha Arora.

Nearly a month after the health minister declared that COVID-19 had been contained, states such as Maharashtra in the west and Kerala in the south have reported a surge in cases, as reluctance grows over mask-wearing and social distancing.

India’s infections are the second highest in the world at 11.03 million, swelled in the past 24 hours by 13,742, health ministry data shows. Deaths rose by a two-week high of 104 to 156,567.

“Any laxity in implementing stringent measures to curb the spread, especially in view of new strains of virus ... could compound the situation,” the ministry said in a statement singling out nine states and a federal territory.

India has confirmed the long-time presence of two mutant variants - N440K and E484Q - in addition to those first detected in Brazil, Britain and South Africa.

The ministry said that while cases in the states of Chhattisgarh, Gujarat, Kerala, Maharashtra, Madhya Pradesh and Punjab, as well as the federal territory of Jammu and Kashmir, were rising, the proportion of high-accuracy RT-PCR tests in those places was falling. Cases have also risen in Karnataka, Tamil Nadu and West Bengal.

In the past week, a third of India’s 36 states and union territories have reported an average of more than 100 new cases each day, with Kerala and Maharashtra both reporting more than 4,000, in a trend experts link to the reopening of schools and suburban train services.

The government has also asked states to speed vaccinations for healthcare and frontline workers. Just about 11 million people have received one or two doses in a campaign that began on Jan. 16, versus a target of 300 million by August.

From March 1, India will start vaccinating people above 60 and those older than 45 with health conditions free of charge in about 10,000 government hospitals and for a fee in more than 20,000 private facilities, the government said.

Earlier on Wednesday, a regulatory panel sought more data from drugmaker Dr. Reddy’s Laboratories for emergency authorisation of Russia’s Sputnik V COVID-19 vaccine, a senior official with direct knowledge of the discussions said.

The Central Drugs Standard Control Organization did not immediately reply to a Reuters request for confirmation.

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